UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000051036
Receipt number R000058187
Scientific Title Scale Characteristics Study of the Self-Assessment of Clinical Reasoning in Occupational Therapy
Date of disclosure of the study information 2023/05/15
Last modified on 2024/04/12 20:28:02

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Basic information

Public title

Scale Characteristics Study of the Self-Assessment of Clinical Reasoning in Occupational Therapy

Acronym

Scale Characteristics Study of SA-CROT

Scientific Title

Scale Characteristics Study of the Self-Assessment of Clinical Reasoning in Occupational Therapy

Scientific Title:Acronym

Scale Characteristics Study of SA-CROT

Region

Japan


Condition

Condition

Occupational Therapists, Occupational Therapy Students

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study was to examine the validity, responsiveness, and interpretability of the Self-Assessment scale of Clinical Reasoning in Occupational Therapy (SA-CROT) as scale properties.

Basic objectives2

Others

Basic objectives -Others

to examine the scale properties (validity, responsiveness, and interpretability) of SA-CROT

Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

the Self-Assessment scale of Clinical Reasoning in Occupational Therapy (SA-CROT)

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

18 years-old <=

Age-upper limit

60 years-old >=

Gender

Male and Female

Key inclusion criteria

Occupational therapy students scheduled for fieldwork (including alternative on-campus practice and hybrids), Occupational therapists with less than 5 years of clinical experience

Key exclusion criteria

Those who are on leave of absence, Those whose fieldwork has been cancelled

Target sample size

400


Research contact person

Name of lead principal investigator

1st name Sho
Middle name
Last name Maruyama

Organization

Tokyo Metropolitan University

Division name

Department of Occupational Therapy, Graduate School of Human Health Sciences

Zip code

116-8551

Address

7-2-10 Higashiogu Arakawa-ku Tokyo

TEL

03-3819-1211

Email

maruyama@tmu.ac.jp


Public contact

Name of contact person

1st name Sho
Middle name
Last name Maruyama

Organization

Tokyo Metropolitan University

Division name

Department of Occupational Therapy, Graduate School of Human Health Sciences

Zip code

116-8551

Address

7-2-10 Higashiogu Arakawa-ku Tokyo

TEL

03-3819-1211

Homepage URL


Email

maruyama@tmu.ac.jp


Sponsor or person

Institute

Tokyo Metropolitan University

Institute

Department

Personal name

Sho Maruyama


Funding Source

Organization

Japan Society for Occupational Therapy Education

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Tokyo Metropolitan University

Address

7-2-10 Higashiogu Arakawa-ku Tokyo

Tel

03-3819-1211

Email

maruyama@tmu.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2023 Year 05 Month 15 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2022 Year 05 Month 24 Day

Date of IRB

2022 Year 06 Month 16 Day

Anticipated trial start date

2022 Year 07 Month 01 Day

Last follow-up date

2024 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Study 1 will be a cross-sectional survey of occupational therapy students, and occupational therapists will examine the validity and interpretability of the SA-CROT.
Study 2 will examine the responsiveness and interpretability of the SA-CROT instrument through a longitudinal survey of occupational therapy students before and after fieldwork.


Management information

Registered date

2023 Year 05 Month 11 Day

Last modified on

2024 Year 04 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058187


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name